4SC AG – RESMAIN Trial Meets Primary Endpoint in Cutaneous T-Cell Lymphoma (CTCL)
4SC AG – RESMAIN Trial Meets Primary Endpoint in Cutaneous T-Cell Lymphoma (CTCL)
- Resminostat met the primary endpoint in the RESMAIN study, demonstrating a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo
- Resminostat is the first and only drug to show statistically proven PFS improvement in the maintenance setting in CTCL
- Resminostat did not meet the key secondary endpoint – time to symptom (pruritus) worsening
- 4SC intends to approach the European Medicines Agency in order to evaluate the preparation of its Marketing Authorization Application
- 4SC also intends to file for Orphan Drug Designation for Resminostat in CTCL in both Europe and the United States
Planegg-Martinsried, Germany, 23 May 2023 – 4SC AG (4SC, FSE Prime Standard: VSC) announced today that resminostat has met the primary endpoint in the RESMAIN study and demonstrated a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo. The study confirmed the already well known safety profile of resminostat in CTCL.
RESMAIN is a pivotal study, conducted as a multi-center, double blind, randomized, placebo-controlled study, evaluating resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at 50 clinical centers in 11 European countries and 5 centers in Japan.
Given that the RESMAIN study did not meet its key secondary objective, 4SC will now approach the European Medicines Agency in order to better understand the feasibility of submitting a Marketing Authorization Application.
In addition, 4SC also intends to file for Orphan Drug Designation for Resminostat in CTCL in both Europe and the United States.
The results of the RESMAIN study will be presented at an upcoming medical meeting.
_________________________________________________________________________
Information and Explanation of the Issuer to this News:
Forward-looking information
Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond 4SC’s control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
About resminostat
Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that potentially offers an approach to treating different kinds of cancer. Resminostat demonstrated that it is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body’s immune response to cancer. Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) as maintenance treatment by 4SC in Europe and by Yakult Honsha in Japan.
About cutaneous T-cell lymphoma (CTCL)
CTCL is a rare disease with approximately 5,000 patients being newly diagnosed in Europe each year. The disease arises from malignant transformation of T-cells, a specialized subgroup of immune cells, primarily affects the skin, but may ultimately involve lymph nodes, blood and visceral organs.
Currently, CTCL is not curable and treatment options for advanced-stage CTCL are limited. Although patients respond to the available treatment options, the duration of response is often short-lived and declines as the severity of the disease increases. The key therapeutic challenge in advanced-stage CTCL is therefore to make remissions more durable by halting disease progression and improving patient’s quality of life.
About the RESMAIN study – resminostat for maintenance treatment of CTCL
The pivotal RESMAIN study is being conducted at more than 50 clinical centers in 11 European countries and Japan. It includes more 201 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) that have achieved disease control with systemic therapy. The patients were randomized 1:1 to receive either resminostat or placebo. Patients who experience disease progression – while being on placebo – will be offered resminostat in an open label treatment arm. The primary goal of the study is to determine whether maintenance treatment with resminostat prolongs progression-free survival. The key secondary objective is to prolong the time to symptom worsening (pruritus).
About the concept of maintenance therapy
The pivotal RESMAIN study is focused on patients with advanced-stage, incurable cutaneous T-cell lymphoma (CTCL). Such patients suffer from painful and itchy skin lesions resulting in disfigurement and a severely impaired quality of life. Furthermore, lymph nodes, blood or visceral organs can be involved. The current therapeutic options rarely provide long-lasting responses or stabilization of disease for meaningful periods, with most patients progressing within several months.
Resminostat is being evaluated as maintenance treatment – a unique innovative treatment approach in CTCL (Stadler et al., 2021) - intended to prolong the period patients are stable and not progressing. Furthermore, recent preclinical data suggests that resminostat has the potential to alleviate the itching in CTCL patients, thereby additionally improving their quality of life.
Upon FDA approval, Advanced Medical Balloons launches innovative hygh-tec catheter system for ICU stool drainage in U.S. market
Upon FDA approval, Advanced Medical Balloons launches innovative hygh-tec catheter system for ICU stool drainage in U.S. market
• Creative Balloons operates under new name Advanced Medical Balloons (AMB)
• AMB’s microscopically thin polyurethane (PUR) balloon catheter systems address indications in intensive care
• 1st product from the ICU portfolio now launched in U.S.: hygh-tec® enables reliable and contamination-free stool drainage
• Strong performance in Germany, with strong market share growth
Waghaeusel (Germany), May 4, 2023 – Advanced Medical Balloons GmbH (formerly Creative Balloons GmbH), a specialist in medical technology from Waghaeusel near Heidelberg, today announced that the company is expanding its intensive care business to the United States. This is based on the approval which has recently been granted by the U.S. Food and Drug Administration (FDA) for their innovative catheter system hygh-tec®.1, 2 The novel fecal management system hygh-tec provides maximum seal and prevention of fecal leakage in patients receiving intensive care.
“We are delighted that the FDA cleared hygh-tec, which is a major milestone for AMB in accessing the U.S. market. Offering the first product from our unique portfolio in the U.S. for medical supply of ICU patients makes us very proud,” said Frank Gehres, CEO of Advanced Medical Balloons. “hygh-tec’s reliably high leak tightness means a significant reduction in workload and saving time for caregivers. The trans-anal sealing mechanism could also support early mobilization of cardiac patients or contribute to preventing infection in severely burnt patients. For physicians, this smart fecal management opens up novel therapeutic possibilities.”
Along with the start of U.S. sales, the company operates globally as Advanced Medical Balloons (AMB) since April 1, 2023. Advanced Medical Balloons Inc. is based in Atlanta, GA, and is currently establishing its own U.S. sales structure under the leadership of experienced General Manager Kent Johnson. “While building out our commercial team, we have initiated clinical use in ICU patients in the U.S. and are rolling out hygh-tec with intensive care clinicians throughout the country,” said Kent Johnson. “We have already seen very encouraging feedback from healthcare professionals confirming their need for a next-generation fecal management system, and I am extremely positive regarding our commercial success.”
Frank Gehres confirms: “While hygh-tec is already established in its lead market Germany, where we currently have almost a quarter of market share in ICUs and are continuously growing, the USA is the most important market for AMB, globally. With approximately 110,000 intensive care beds, we see a market potential in the mid three-digit million range. I am therefore very pleased that we have been able to win Dr. Ramona Koenig as Chief Operating Officer to support the roll-out of our products and the expansion of our business activities.” Ramona Koenig, a trained physicist with a PhD in physical chemistry, joined AMB on March 1, 2023, from Rottendorf Pharma.
The technical basis for hygh-tec is its innovative design of the elastic and deformable polyurethane catheter tube, which allows an unmatched trans-anal sealing performance. It clings to the rectal mucosa free from tension and spontaneously adapts to the sphincter dynamics and movements of the patient.
By adapting to the current pressure, intelligent synchronization with the sphincter is possible. When the tone decreases and the sphincter muscle opens, the sheath can spontaneously straighten in the anal canal and allows unobstructed defecation.
About Advanced Medical Balloons
Advanced Medical Balloons (AMB) is a specialized medical technology company. The company develops and markets novel catheter technology based on microscopically thin, complex shaped balloon films made of polyurethane (PUR). AMB taps the properties of these extraordinary structures for problem-solving platform concepts in the Fecal, Urinary and Respiratory segments. The current focus is on systems for the containment of patient contamination. In this context, AMB is developing contamination-free drainage technology for fecal management in intensive care patients, which provides significant benefits in nursing, hygiene management and patient therapy. The first product utilizing this technology, hygh-tec®, is already used in German-speaking countries with great success and since 2023 also marketed in the USA. AMB was founded in 2009 by Dr. med. Fred Göbel and is based in Waghäusel, near Heidelberg, Germany, and in Atlanta, GA, USA. https://www.amb-medtec.com/en/
Contact:
Advanced Medical Balloons GmbH
Frank Gehres, CEO
Phone: +49-7254-4039710
Media relations:
MC Services AG
Eva Bauer
Phone: +49-89-210228-0
1 From the letter of authorization: “The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administration of medications. The device is not intended for use on pediatric patients.” U.S. Food and Drug Administration, 2023
2 hygh-tec® is a registered trademark of Advanced Medical Balloons GmbH.
Immatics Reports Interim Clinical Data from Ongoing Phase 1b Cohort A Monotherapy with ACTengine® IMA203 TCR-T Targeting PRAME
Immatics Reports Interim Clinical Data from Ongoing Phase 1b Cohort A Monotherapy with ACTengine® IMA203 TCR-T Targeting PRAME
Company to host conference call today, May 2, at 8:30 am EDT / 2:30 pm CEST
- Update covers data from 11 heavily pre-treated, last-line patients in Phase 1b dose expansion Cohort A treated with IMA203 TCR-T monotherapy against PRAME
- Objective response rate (ORR): 64% (7/11) initial ORR at week 6 and 67% (6/9) confirmed ORR at month 3
- Median duration of response not reached at median follow-up time of 8.5 months at data cut-off
- Objective responses independent of solid tumor type at low, medium and high PRAME expression levels in checkpoint-refractory cutaneous melanoma, platinum-resistant ovarian cancer, uveal melanoma, head and neck cancer and synovial sarcoma
- Cohort A IMA203 monotherapy TCR-T treatment continues to show manageable tolerability with no high-grade CRS and no ICANS; no dose dependent increase of CRS observed
- Proprietary rapid manufacturing process with 7 days of manufacturing time; manufacturing success rate of 94% to reach current recommended Phase 2 dose
- Next data update and pathway towards registration-directed trials planned to be set out in 4Q 2023
- Company well capitalized with cash position1 of $386m at YE 2022 and reach into 2025 to leverage multi-cancer PRAME opportunity
Houston, Texas and Tuebingen, Germany, May 2, 2023 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced an interim clinical data update for 11 patients with recurrent and/or refractory solid cancers treated with ACTengine® IMA203 TCR-T monotherapy in the ongoing Phase 1b dose expansion Cohort A. IMA203 TCR-T cells are directed against an HLA-A*02-presented peptide derived from PRAME, a broadly expressed solid cancer target with clinical proof-of-concept for IMA203 demonstrated by Immatics in 2022. Overall, IMA203 showed a high rate of deep and durable objective responses, with a confirmed objective response rate of 67% (6/9), across multiple tumor types, including two confirmed partial responses (cPR) ongoing at more than 9 months after treatment and three additional partial responses ongoing at data cut-off. IMA203 monotherapy continues to be well tolerated in heavily pre-treated patients at doses of up to approximately 9 billion CD8+ TCR-T cells. No high-grade cytokine release syndrome (CRS) and no immune effector cell associated neurotoxicity syndrome (ICANS) were observed in Cohort A at data cut-off.
The data will be presented by Martin Wermke, MD, Professor at the University Hospital Dresden and Coordinating Investigator of the ACTengine® IMA203 TCR-T trial during a conference call today, May 2, at 8:30 am EDT / 2:30 pm CEST.
“The treatment of solid cancer patients who have exhausted all available standard of care options remains a significant challenge. These patients typically show fast progressing disease with very poor prognosis,” said Martin Wermke, MD, Coordinating Investigator of the ACTengine® IMA203 TCR-T trial. “It is therefore very encouraging to see that IMA203 is able to provide durable, clinically relevant responses in a variety of solid cancer patients.”
“Today marks a significant step in our efforts towards bringing our ACTengine® IMA203 monotherapy to patients with solid tumors, as we present for the first time longer-term clinical data demonstrating deep and durable responses, some of them ongoing beyond 9 months after treatment,” commented Cedrik Britten, MD, Chief Medical Officer at Immatics. “Furthermore, we show that these responses are agnostic of tumor type and that ACTengine® IMA203 achieved objective responses at widely differing PRAME expression levels. These data further increase our confidence in the success and broad potential of targeting PRAME, and our product candidate IMA203. We continue executing and anticipate announcing a potential fast-to-market pathway for the first 1-2 indications by the end of the year.”
Safety data for IMA203 TCR-T monotherapy in Phase 1b Cohort A: Treatment with IMA203 monotherapy continues to show manageable tolerability at doses as high as ~9×109 TCR-T cells.
- At data cut-off on April 4, 2023, 11 PRAME-positive patients were infused with IMA203 TCR-T cells at dose level (DL) 4 or DL5 with a mean total infused dose of 3.67×109 TCR-T cells (range 1.30-8.84×109 TCR-T cells).
- Based on data review of 6 patients in the exploratory highest DL5, this DL was cleared by the DSMB (Data and Safety Monitoring Board) for safety, and the updated provisional recommended Phase 2 dose (RP2D) now includes DL4 and DL5. The final RP2D will be defined prior to starting Phase 2.
- Most frequent treatment-emergent adverse events (TEAEs) were as expected for cell therapies.
- All 11 patients experienced expected cytopenia (Grade 1-4) associated with lymphodepletion. 10 patients (91%) had a low to moderate (Grade 1-2) cytokine release syndrome (CRS), of which 5 patients (45%) had Grade 1, and 5 patients (45%) had Grade 2 CRS. No high-grade (Grade 3 or higher) CRS and no immune effector cell associated neurotoxicity syndrome (ICANS) were observed in any of these 11 patients. No dose-dependent increase of CRS was observed across Phase 1a and Phase 1b Cohort A (N=38 patients infused with IMA203 in total).
- No additional dose limiting toxicities (DLT) were observed in Cohort A since the initial Phase 1a dose escalation.
Clinical activity for IMA203 TCR-T monotherapy in Phase 1b Cohort A: IMA203 monotherapy demonstrates a high rate of deep objective responses with ongoing durability of more than 9 months after treatment in some patients.
- At data cut-off on April 4, 2023, 11 patients were infused with IMA203 TCR-T cells and evaluable for at least one tumor response assessment post treatment.
- Objective responses were observed in last-line solid cancer patients including cutaneous melanoma, ovarian cancer, uveal melanoma, head and neck cancer, synovial sarcoma.
- Patients were heavily pre-treated with a mean of ~4 lines of prior systemic treatments and had exhausted all available standard of care treatments.
- All cutaneous melanoma patients were checkpoint inhibitor-refractory, all ovarian cancer patients were platinum-resistant.
- Initial objective response rate (ORR) of 64% (7/11) was observed at ~week 6 (partial responses, PR, according to RECIST 1.1).
- Confirmed ORR of 67% (6/9) was observed at ~month 3; initial responses at week 6 were confirmed for all 6 responders with available subsequent 3-month scan.
- Median duration of response2 was not reached (min 1.3+ months, max 8.8+ months) at a median follow-up3 of 8.5 months.
- At data cut-off, 5 of 7 responses remain ongoing:
- 2 cPRs (cut. & uveal melanoma) ongoing at 9+ months
- 1 cPR (cut. melanoma) ongoing at 6+ months
- 1 cPR (ovarian cancer) ongoing at ~3 months
- 1 PR (synovial sarcoma) ongoing at 6+ weeks
- Objective responses were observed in patients independent of tumor type at all PRAME expression levels above Immatics’ mass spectrometry-guided RNA threshold including expression levels at or just above this threshold.
- IMA203 T cells were found in all evaluable tumor tissues and the level of tumor infiltration was associated with objective responses.
Best Overall Response – Phase 1b Cohort A
1 Ovarian cancer patient A-DL5-04 erroneously received one dose of nivolumab and is part of intent-to-treat population (shown here) but not per-protocol population; NET: Neuroendocrine Tumor; PD: Progressive disease; SD: Stable disease; PR: Partial response; cPR: Confirmed partial response; BL: Baseline; BOR: Best Overall Response
Response over Time – Phase 1b Cohort A
Manufacturing of IMA203 TCR-T cells
- Immatics’ proprietary manufacturing process has a manufacturing time of 7 days (+7-day expedited release testing), with a success rate of 94% in achieving the provisional RP2D.
- Manufacturing improvements (including monocyte depletion) and higher applied cell doses implemented for the Phase 1b part of the trial led to significantly increased levels of IMA203 T cells in the blood of patients in Phase 1b Cohort A compared to patients in the Phase 1a dose escalation.
- Immatics is currently building a state-of-the-art facility designed to manufacture ACTengine® IMA203 TCR-T products, as well as other cell therapy candidates, for registration-directed trials and initial commercial supply. Built with flexibility and cost-efficiency in mind, the facility is designed to be scalable via a modular design to accommodate manufacturing demands. The facility is expected to be operational in 2024.
Development strategy to realize the multi-cancer opportunity PRAME
Immatics believes, the results presented today further validate PRAME as one of the most promising solid tumor targets for TCR-based therapies. Immatics’ IMA203 development strategy is based on two pillars aimed initially at a (1) fast-to-market approach and, later at a (2) broad development.
The first objective is to deliver the PRAME-targeted TCR-T cell therapy in 1-2 last-line solid cancer types as fast as possible with a focus on indications with PRAME prevalence above 80% and where clinical proof-of-concept has been demonstrated, such as cutaneous melanoma (potentially bundled with uveal melanoma) and/or ovarian cancer. The buildout of the manufacturing facility will support Immatics’ efforts to maximize speed to market. Immatics plans to start a first Phase 2 trial in 1H 2024, which is intended to be designed as a registration-directed trial.
As a second step, Immatics plans to also expand development to other cancer types, such as uterine cancer, lung cancer, breast cancer, head and neck cancer and other tumor types having a broad patient reach.
An update on all three IMA203 Phase 1b Cohorts and clinical development path for PRAME TCR-T monotherapy towards registration-directed trials and potential commercialization is planned for 4Q 2023.
In addition to ACTengine® TCR-T, Immatics is addressing PRAME-positive cancers with a second therapeutic modality, TCR Bispecifics (TCER®), to leverage the full potential of the multi-cancer opportunity PRAME. Immatics’ TCER® IMA402 is a next-generation, half-life extended TCR Bispecific for which Immatics submitted a clinical trial application (CTA4) to the Paul-Ehrlich-Institute (PEI) on April 14, 2023, to initiate the Phase 1/2 trial. The trial is expected to commence in 2H 2023 with first clinical data planned in 2024.
Both approaches, ACTengine® and TCER®, are distinct therapeutic modalities that have the potential to provide innovative treatment options for a variety of cancer patient populations with different medical needs. Immatics will continue to evaluate which of these therapeutic modalities (ACTengine® vs. TCER® or both) is best suited for each cancer type.
Immatics conference call
Immatics will host a conference call today, May 2nd, 2023, at 8:30 am EDT / 2:30 pm CEST to discuss the clinical data. The webcast and presentation can be accessed directly through this link. Participants may also access the slides presented in the webcast on the Immatics website in the Investors section under “Presentations” at www.investors.immatics.com/events-presentations. A replay of the webcast will be made available shortly after the conclusion of the call and archived on Immatics website for at least 90 days.
About IMA203 and target PRAME
ACTengine® IMA203 T cells are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers, thereby supporting the program’s potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine® IMA203.
ACTengine® IMA203 TCR-T is currently being evaluated in three ongoing Phase 1b dose expansion cohorts in last-line patients: Cohort A IMA203 TCR-T monotherapy, Cohort B IMA203 in combination with an immune checkpoint inhibitor; Cohort B is focused on generating safety data for potential further investigation of a combination approach as a front-line therapy, and Cohort C IMA203CD8 TCR-T monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor. IMA203CD8 is currently being explored in DL4a (up to 0.8×109 TCR-T cells/m2 BSA).
About ACTengine®
ACTengine® is a personalized cell therapy approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine® product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.
The ACTengine® T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine® Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).
– END –
About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on Twitter, Instagram and LinkedIn.
Forward-Looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics’ focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.
For more information, please contact:
| Media and Investor Relations Contact | |
| Eva Mulder or Charlotte Spitz | |
| Trophic Communications | |
| Phone: +31 65 2331 579 | |
| Immatics N.V. | |
| Anja Heuer | Jordan Silverstein |
| Senior Director, Corporate Communications | Head of Strategy |
| Phone: +49 89 540415-606 | Phone: +1 281 810 7545 |
1 Cash position includes cash and cash equivalents as well as other financial assets and was €362.2 million as of December 31, 2022 ($386.3 million using the exchange rate published by the European Central Bank in effect as of December 31, 2022 (1 EUR = 1,0666 USD).
2 Duration of response (DOR) in confirmed responders is defined as time from first documented response until disease progression/death. Patients with ongoing response will be censored at date of data cut-off. Median DOR is analyzed by using the Kaplan-Meier method.
3 Median follow-up is analyzed by using the reverse Kaplan-Meier method.
4 Clinical Trial Application (CTA) is the European equivalent of an Investigational New Drug (IND) application.
UroMems Granted Safer Technologies Program Designation from FDA for Smart Implant to Treat Stress Urinary Incontinence
UroMems Granted Safer Technologies Program Designation from FDA for Smart Implant to Treat Stress Urinary Incontinence
STeP inclusion reflects the potential improvements in safety of its UroActive™ System
GRENOBLE, France and MINNEAPOLIS, April 20, 2023 /PRNewswire/ — UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive Smart Continence Therapy. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices.
“We are delighted to receive this designation and excited to advance the development of our UroActive system – the first-of-its-kind fully automated AUS implant designed to treat SUI in both men and women,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “We thank the FDA for acknowledging the importance of safety above all for patients.”
UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS). This innovative system is placed around the urethral duct and is automatically controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.
SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the muscle (the sphincter) around the urethra, caused by activities involving high intra-abdominal pressure, like coughing, laughing and exercising. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. While mild SUI is addressed by pelvic floor re-education and bulking agents, moderate and severe SUI historically have only had two options: mesh sling or artificial urinary sphincter.
“The STeP approval is proof that the FDA recognizes the potential for UroActive to improve upon safety for patients with severe SUI, while also designed for an improved surgical experience for the OR team, surgeons and most importantly, their patients,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder.
UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from poorly treated chronic conditions by the commitment to change the perception that these disorders are inevitable as one grows older and is simply something to endure with no real solution. UroMems is revolutionizing the treatment of SUI with smart active implants, using the latest technological advances in the field of embedded systems and micro-technologies for the development of its groundbreaking solutions.
About STeP
Launched in January of 2021, the FDA’s Safer Technologies Program is a voluntary program for certain medical devices and device-led combination products that have the potential to be safer than currently available treatments or medical diagnostics. The program is intended to help patients have more timely access to products by expediting their development, assessment, and review, while maintaining the FDA’s standards for safety and effectiveness, data requirements, and quality of review.1
STeP participation does not imply product authorization. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States.
About UroActive
UroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bionic platform using embedded smart, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems technology platform is protected by more than 100 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience.
About UroMems
Founded in 2011 by Professor Pierre Mozer, Hamid Lamraoui and Stéphane Lavallée, UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated chronic conditions by the commitment to change the perception that these disorders are inevitable as one grows older and is simply something to endure with no real solution. The first challenge for the company will be applying embedded mechatronics methods and smart systems for treating urinary incontinence. Designed by urologists and collaborating scientists and engineers, UroActive intends to provide a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.
Since the inception of the company, significant investments have been made for the development of UroMems’ first product. This includes two financing rounds totaling 46 million euros, led by Wellington Partners, Bpifrance, Supernova Invest, b-to-v Partners AG, Cita Investissement, Hil-Invent, Financière Arbevel and the founders. The company has received several awards for innovation, including the Prix Galien Award Medstart’up and the Worldwide Innovation Challenge initiated by the French government. For more information, please visit www.uromems.com.
1 https://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2023
Media Contact
Shelli Lissick
651-276-6922
SOURCE UroMems
MinervaX Commences First Phase 1 Clinical Study of Novel GBS Vaccine in Older Adults
MinervaX Commences First Phase 1 Clinical Study of Novel GBS Vaccine in Older Adults
• Expands development of novel GBS vaccine in older adult population
• Targeting significant and growing unmet medical need of GBS infection
Copenhagen, Denmark, 17 April 2023 – MinervaX ApS, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS), announces the first phase 1 clinical study in older adults of its novel GBS vaccine, at CEVAC (Centre for Vaccinology) in Ghent, Belgium.
GBS is a global unmet medical burden and can cause serious illness in people of all ages, worldwide. It is normally associated with infection in pregnant women and new-born babies; however, invasive GBS disease in adults has been increasing over the last 40 years. The older adult population (>65 years of age) and adults with underlying chronic health conditions (diabetes mellitus, cancer, immune suppression, obesity) are at particular risk of invasive GBS disease. There is currently no vaccine available.
The clinical study will investigate the safety and immunogenicity of two dose levels on the MinervaX novel GBS vaccine in an older adult population from 55 to 75 years of age, with and without underlying medical conditions. The trial will investigate the safety and immune response to the dose level currently under development for use in pregnant women (50 μg of each fusion protein) and a higher dose of 125 μg of each fusion protein. Since older adults, certainly those with comorbidities, often mount a less strong immune response than a younger population, up to three doses will be investigated in this trial [clinicaltrials.gov under the identifier NCT05782179].
MinervaX has completed enrolment and dosing of its 2nd phase II clinical trial of its novel GBS vaccine in pregnant women across Denmark, the UK and South Africa. Details of MinervaX’s ongoing clinical trials can be found at clinicaltrials.gov under the identifiers NCT04596878 and NCT05154578.
Lidia Oostvogels, Chief Medical Officer of MinervaX, said: “Expanding the development of our GBS vaccine for use in an older adult population, including people with increased risk for GBS due to underlying co-morbidities, is a very important step for MinervaX in the battle against this pathogen. This builds on our efforts and experience to develop a product to provide protection to the most vulnerable populations, i.e., neonates in our maternal immunization program, and now older adults including those with certain co-morbid conditions.”
Prof. Isabel Leroux-Roels, Principal Investigator at CEVAC, commented: “GBS is known to cause potentially life-threatening infections in Older Adults and currently there is no vaccine available to prevent this. All the team at CEVAC are very happy to contribute to the development of this vaccine for this high-risk population.”
Prof. Paul Heath, Director of the St George’s Vaccine Institute, London and Lead Investigator of MinervaX’s Phase IIb study across Denmark, the UK and South Africa, remarked: “Streptococcus agalactiae is a common commensal in humans and approximately 25% of all adults will be colonised with GBS in the gastrointestinal or genitourinary tracts at any given time. We are aware of the considerable global burden of this invasive GBS disease in babies and pregnant women and of the urgent need for a vaccine to prevent this. More recently, we have become aware of the burden of GBS in non-pregnant adults, particularly in older adults, and those with underlying health conditions such as diabetes mellitus. There is no current mechanism for preventing GBS disease in this growing population, and there is a well recognised morbidity and mortality. The need for a vaccine for this group of people is therefore urgent and the commencement of GBS vaccine trials in this population is therefore an important and welcome development.”
For further information please contact:
MinervaX
Per Fischer | Chief Executive Officer
Email:
Optimum Strategic Communications
Mary Clark / Jonathan Edwards/ Zoe Bolt
Email:
Tel: +44 (0) 203 882 9621
Notes to Editors:
About MinervaX
MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, and now also for vaccination of older adults, likely to have superior characteristics compared with other GBS vaccine candidates in development. The latter are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX’s vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS (the Alpha-like protein family). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX’s vaccine will confer protection against virtually 100% of all GBS isolates. www.minervax.com
About Group B Streptococcus (GBS)
Streptococcus agalactiae or Lancefield’s Group B Streptococcus (GBS) is a common commensal in humans, approximately 25% of all adults will be colonised with GBS at any given time. Invasive GBS disease is normally associated with infection in pregnant women and new-born babies; however, invasive GBS disease in adults has been increasing over the last 40 years. The older adult population (>65 years of age) and adults with underlying chronic health conditions (diabetes mellitus, cancer, immune suppression, obesity) are at particular risk of invasive GBS disease.
Group B Streptococcus disease in non-pregnant adults causes secondary and primary bacteraemia, septic arthritis, endocarditis, prosthetic joint infection, and necrotising myositis and fasciitis.
It is apparent that outside of pregnancy and the neonatal period, GBS infection results in high morbidity and mortality rates. There is no preventative treatment, cases are managed with antibiotics when an infection is diagnosed. There is a clear unmet medical need for a preventative vaccine that could provide protection to all adults but particularly to the older adult population or those at risk of infection due to underlying medical or demographic conditions. In addition, the incidence is increasing and will probably continue to increase with an increasing older adult population and an increase in the prevalence of obesity and type 2 diabetes around the world.
Sidekick Health chosen as partner for White House’s CancerX project to rapidly accelerate the pace of cancer innovation in the U.S.
Sidekick Health chosen as partner for White House’s CancerX project to rapidly accelerate the pace of cancer innovation in the U.S.
Recently announced by U.S. President Joe Biden and Dr. Jill Biden as part of the reignited national Cancer Moonshot initiative, Sidekick is one of 15 organizations chosen to help tackle the root causes of health inequity and accelerate digital innovation to solve some of the most pressing challenges facing patients with cancer.
Sidekick Health today announces that it will be a partner on the inaugural CancerX project, a public-private partnership that was recently launched by U.S. President Joe Biden and Dr. Jill Biden as part of the reignited national Cancer Moonshot initiative. The project, co-hosted by the Digital Medicine Society (DiMe) and Moffitt Cancer Center, aims to unite the diverse stakeholders and innovators necessary to design and create a future that is dedicated to improving cancer outcomes.
The Cancer Moonshot initiative has ambitious goals to cut the death rate from cancer by at least 50% over the next 25 years and to improve the experience of people and their families living with and surviving cancer. The inaugural project, “Advancing Digital Innovation to Improve Equity and Reduce Financial Toxicity in Cancer Care and Research,” is already formed and will start work in early April. It will focus on the root causes of financial toxicity (a term used to describe how out-of-pocket costs related to cancer care can result in financial problems for patients and their families) and health inequity to accelerate human-centered digital innovation to solve some of the most pressing challenges facing cancer patients, providers, and researchers.
In 2023, the American Cancer Society reported that there would be an estimated 1.9 million new cancer diagnoses, yet innovative digital approaches for delivery and precision oncology care remain limited. Existing approaches are also not yet applied at scale to minimize the burden of financial toxicity to patients with cancer and reduce the associated healthcare access, outcome, and economic disparities. The opportunity to improve cancer care and outcomes is clear and significant. For digital innovation to deliver on its potential to improve the lives of all people with cancer, prioritization of opportunities for the greatest impact is key. This includes improving access, equity, and inclusion when developing and deploying digital solutions for cancer care.
By identifying the biggest areas of potential impact, developing actionable tools, and providing incentive models, Sidekick, alongside other partner organizations, will share its wealth of expertise in digital therapeutics and help pave the way in fulfilling the promise of digital innovation across the full continuum of care.
Through partnerships with health insurers and pharmaceutical companies, Sidekick’s unique platform already supports people living with cancer both in the US and Europe. For example, in a strategic collaboration with Eli Lilly, Sidekick provides patients living with breast cancer access to a tailored digital health plan, engaging in health-improving tasks which promote behavior modification and overcome barriers to change. It focuses on five main areas: stress management, physical activity, diet, sleep, and medication adherence, the latter representing a significant obstacle to recovery in patients undergoing cancer treatment. Patients are also given access to educational content that has been created in close collaboration with clinical experts, patients, and patient advocacy groups, helping to provide them with unique insights into living with cancer. Sidekick also delivers programs for other chronic conditions, such as obesity and cardiometabolic diseases, and promotes a personalized approach through adaptive care pathways. As part of the CancerX project, Sidekick will help champion the value of high-quality digital innovation in cancer, address methodological gaps where they exist, and define best practices for successful and equitable implementation.
Confo Therapeutics Enters into Collaboration Agreement with Daiichi Sankyo to Discover Novel Medicines for CNS Diseases
Confo Therapeutics Enters into Collaboration Agreement with Daiichi Sankyo to Discover Novel Medicines for CNS Diseases
- Collaboration to make use of Confo’s unique suite of ConfoBody®-enabled technologies for fragment- and structure-based drug design
- Confo to receive upfront and milestone payments totaling EUR 168M
- Tiered royalties payable to Confo on net sales from resulting products
Ghent, Belgium – March 30, 2023 – Confo Therapeutics, a leader in the discovery of medicines targeting G-protein coupled receptors (GPCRs), today announced that it has entered a collaboration agreement with Daiichi Sankyo (TSE: 4568) for the discovery and development of small molecule agonists against an undisclosed target associated with CNS diseases.
Under the terms of the agreement, Confo will lead the discovery process deploying its GPCR platform to generate lead series of small molecule compounds. Daiichi Sankyo has an exclusive option to acquire a worldwide exclusive license for the resulting compounds and advance them towards clinical development and commercialization. Confo has the potential to receive upfront payments, development and commercial milestones totaling EUR 168M and royalties.
“Daiichi Sankyo has historically been at the forefront of leveraging innovative technologies to develop novel medicines. We are excited by this collaboration in which we will be using Confo’s expertise and platform to pursue a previously undruggable GPCR target in an area of high unmet medical need,” said Cedric Ververken, CEO of Confo Therapeutics. “As we expand the scope of our internal drug discovery and development efforts, we look forward to continuing to enter partnerships with leading innovators to create new therapeutic options for patients.”
About Confo Therapeutics
Confo Therapeutics’ unparalleled technology stabilizes functional conformations of GPCRs (G protein-coupled receptors), thereby enabling the discovery of chemical or biological ligands that are conformationally selective. This platform combined with the pharmacologic and biologic insight it provides, allows Confo to build a multi-indication pipeline of drug candidates with the vision of transforming therapeutic outcomes for patients with severe illnesses lacking disease-modifying treatments. Confo Therapeutics was spun out of VIB-VUB (Vrije Universiteit Brussel) in 2015. Supported by international life-science focused investors and led by an experienced team of entrepreneurial professionals and scientists from successful biopharmaceutical companies, Confo Therapeutics benefits from the rich scientific and innovative ecosystem in Belgium.
For more information, visit www.confotherapeutics.com
For more information, please contact:
Confo Therapeutics
Dr. Cedric Ververken, CEO
+ 32 (0) 9 396 74 00
ImCheck Appoints Thomas Civik as Independent Chairman of the Board
ImCheck Appoints Thomas Civik as Independent Chairman of the Board
Marseille, France, March 23, 2023 – ImCheck Therapeutics announced today the appointment
of Thomas Civik as independent Chairman of its Board of Directors. With a distinguished career
of 30 years in the biopharmaceutical industry, Mr. Civik has extensive experience in bringing
oncology innovations to patients and from executive leadership roles, most recently as CEO of
Five Prime Therapeutics. He will join ImCheck’s Board as the company further develops its lead
program ICT01 and a range of antibody therapeutics targeting butyrophilins,
a novel superfamily of immunomodulators. Dr. Debasish Roychowdhury, Chairman since 2018, will step
down from the Board and remain an advisor to the company.
“Welcoming Tom to our Board represents an important milestone as we transition into a more mature
organization advancing a broad and promising pipeline of immunomodulatory antibodies. With our
lead program ICT01 moving toward later-stage clinical evaluation, Tom will make important strategic
contributions through his experience and insights in clinical and corporate development. He will also
provide an extensive network in the U.S. as we continue to expand our footprint there,” said Pierre
d’Epenoux, Chief Executive Officer of ImCheck Therapeutics. “I would like to thank Debasish for
his steadfast support and guidance over the past five years.”
Mr. Civik added: “ImCheck has established a leadership position in gamma delta T-cell activation in
immuno-oncology and has created substantial value through the potential of its unique approach. I
look forward to joining ImCheck’s Board and being a part of the next exciting phase of the company’s
evolution.”
Thomas Civik’s most recent corporate position was as CEO and President of Five Prime
Therapeutics, where he oversaw the clinical development of the company’s oncology pipeline
and the acquisition by Amgen in 2021. Prior to that, he was the Chief Commercial Officer at
Foundation Medicine and led the launch of the first-ever, FDA-approved pan-cancer
comprehensive genomic test. Mr. Civik spent the majority of his career at Genentech, where
for over 15 years, he held increasing levels of responsibility, lastly as Vice President and
Franchise Head, after starting in the pharmaceutical industry at Sanofi. He holds an MBA from
the Kellogg School of Management at Northwestern University and currently serves on the
Board of Directors at Repare Therapeutics and Pyxis Oncology.
About IMCHECK THERAPEUTICS
ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic
antibodies targeting butyrophilins, a novel super-family of immunomodulators.
As demonstrated by lead clinical-stage program ICT01, which has a mechanism of action to
simultaneously modulate innate and adaptive immunity, ImCheck’s “first-in-class” activating
antibodies may be able to produce superior clinical results as compared to the first-generation
of immune checkpoint inhibitors and, when used in combination, to overcome resistance to this
group of agents. In addition, ImCheck’s antagonist antibodies are being evaluated as potential
treatments for a range of autoimmune and infectious diseases.
Co-founder of the Marseille Immunopole cluster, ImCheck benefits from support from Prof.
Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille Université), a worldwide
leader in γ9δ2 T cells and butyrophilins research; from the experience of an expert management
team; and from the commitment of leading US and European investors.
For further information: https://www.imchecktherapeutics.com/
Press contacts:
US and EU
Trophic Communications
Gretchen Schweitzer
+49 (0) 172 861 8540
France
ATCG PARTNERS
Céline Voisin
+33 (0)9 81 87 46 72 / +33 (0)6 62 12 53 39
Seamless Therapeutics Launches with $12.5M Seed Financing to Advance Transformative Gene Editing Platform Based on Programmable Precision Designer Recombinases
Seed round co-led by Wellington Partners and Forbion, with non-dilutive funding from BMBF GO-Bio enables maturation of platform and pipeline towards first clinical evaluation
Dresden, Germany, March 16, 2023 – Seamless Therapeutics today announced a $12.5 million (€11.8M) seed financing round which will accelerate further development of its designer recombinases, a novel gene editing platform to transform the treatment of severe diseases. The company’s pioneering recombinase platform is able to program a widely used and established molecular biology tool to unlock the full potential of gene editing enabling the targeting of any site within the genome. The seed round was co-led by Wellington Partners and Forbion and includes non-dilutive financing from BMBF GO-Bio, a prestigious German government initiative aimed at supporting the most innovative startups in the life sciences. Representatives from both Wellington and Forbion will join the company’s newly formed board of directors. The proceeds from the round will be used to further advance the company’s proprietary technology platform to build a pipeline of therapeutic candidates towards first-in-human readiness as well as to expand the company’s presence in the EU & US.
Seamless Therapeutics was founded based on ground-breaking discoveries from its scientific founders, Prof. Dr. Frank Buchholz, Dean of Research at the Faculty of Medicine and Head of Systems Biology at the University Cancer Center of the Technische Universität Dresden, and Felix Lansing, PhD, Co-Founder and Chief Scientific Officer of Seamless Therapeutics. Both are pioneers in reprogramming recombinases. Felix Lansing, PhD, will be responsible for the continued development of the company’s proprietary technology.
“Our goal is to apply our deep understanding of recombinases to leverage their inherent benefits to repair genetic alterations that cause disease. We believe our pioneering technology will allow us to shatter the boundaries that exist in gene editing methods today,” said Anne-K. Heninger, PhD, Co-Founder and Chief Executive Officer of Seamless Therapeutics. “Both Wellington and Forbion are visionaries and highly experienced biotech investors, and we look forward to working closely with them in our efforts to transform the gene editing landscape.”
“Our modular platform has succeeded in reprogramming site-specific recombinases to any given target sequence effectively breaking the existing hurdles of leveraging this potential best-in-class gene editing system to treat human disease,” commented Felix Lansing, Co-Founder and Chief Scientific Officer of Seamless Therapeutics. “I look forward to working with our founding investors and our highly skilled team to apply our deep knowledge of recombinases to develop a pipeline of novel treatments.”
“We have entered a new era in drug discovery based on the promise of how precision gene editing can change the way we treat disease in the future. Seamless Therapeutics has a first-mover position with its innovative platform capable of modifying the long held standard recombination technology into a universal gene editing tool with unprecedented specificity. We are excited to support Seamless Therapeutics in its pursuit of taking a leadership position in the rapidly evolving gene editing arena,” added Karl Nägler, PhD, Managing Partner at Wellington Partners.
“At Forbion our philosophy is to seek out pioneering technologies early in their development and to enable founding teams to harness the true potential of their innovation. The team has developed a powerful new platform that has overcome key limitations of existing gene editing tools, such as CRISPR, prime & base editors,” said Dmitrij Hristodorov, PhD, Partner at Forbion.
Seamless Therapeutics’ platform has succeeded in reprogramming site specific recombinases to any given target sequence and make a range of specific changes including inversion, excision, exchange, and insertion from small to larger DNA fragments. Recombinases are a class of enzymes that have been widely used in scientific research for decades to precisely modify the genome of model organisms but until now could not be applied as a therapeutic due to their limited programmability to act on new target sites.
***
About Seamless Therapeutics
Seamless Therapeutics is changing the paradigm of gene editing through a pioneering approach to restore health in patients with severe conditions in a safe and precise manner. Our technology platform unlocks the reprogramming of recombinases, a highly versatile class of enzymes. We are applying our proprietary know-how to develop a pipeline of disease-modifying product candidates across a broad spectrum of indications to expand the therapeutic potential of gene editing.
About Wellington Partners
Wellington Partners is a leading European venture capital firm investing in the most promising early- and growth stage life science companies in the fields of biotechnology, therapeutics, medical technology, diagnostics and digital health. With funds totaling more than €1.2 billion, thereof €590 million committed to life sciences, Wellington Partners has been actively supporting world class private companies translating true innovation into successful businesses with exceptional growth. To date, Wellington Partners has invested in 56 innovative life science companies, including Actelion (acquired by J&J), Definiens (acquired by AZ), Immatics (Nasdaq: IMTX). invendo (acquired by Ambu), MTM Laboratories (acquired by Roche/Ventana), Oxford Immunotec (acquired by PerkinElmer), Rigontec (acquired by MSD), Symetis (acquired by Boston Scientific), and Themis (acquired by MSD).
About Forbion
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio) pharmaceutical space. Forbion manages well over EUR 2.3 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in 95 companies. Besides financial objectives, Forbion selects investments that will positively affect the health and wellbeing of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BioGeneration Ventures (BGV), the manager of seed and early-stage funds, especially focused on Benelux and Germany.
About BMBF GO-Bio
The BMBF funding initiative GO-Bio supports life science researchers with innovative ideas who are looking to go into business. It provides excellent conditions from an early project stage on for a successful switch from the lab to the economy.
https://www.go-bio.de/gobio/de/go-bio/go-bio/go-bio_node.html
For more information, please contact:
Seamless Therapeutics
Dr. Anne-K. Heninger, CEO
Phone: +49 351 212 469 0
Email:
Seamless Therapeutics media inquiries
Trophic Communications
Desmond James / Stephanie May
Tel: +49 1516 7859086 or +49 171 1855682
Email:
Carisma Therapeutics Closes Merger with Sesen Bio
Carisma Therapeutics Closes Merger with Sesen Bio
Shares of Carisma to commence trading on Nasdaq under new ticker symbol “CARM” on March 8, 2023
Resulting cash position of approximately $140 million provides runway through 2024; expected to enable multiple clinical readouts across Carisma programs
PHILADELPHIA, March 7, 2023 /PRNewswire/ — Carisma Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, and Sesen Bio, Inc. (“Sesen Bio”), announced today the closing of their previously announced merger. The combined company will operate under the name Carisma Therapeutics Inc. and shares of its common stock will commence trading under the ticker symbol “CARM” on March 8, 2023 on the Nasdaq Global Market.
“This merger represents a very exciting opportunity for stockholders of each company, and we believe it gets us one step closer to our goal of revolutionizing the field of immunotherapy,” said Steven Kelly, President and Chief Executive Officer of Carisma. “It will provide us with the financial strength to not only continue to develop our lead candidate CT-0508 but also accelerate the growth of our platform and pipeline within and outside of oncology and continue to develop additional strong strategic partnerships.”
Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio, said, “I want to thank the entire Sesen Bio team for their steadfast commitment to our mission to save and improve lives. Patients, caregivers and investigators around the world have been important advocates of Sesen Bio and I want to thank them for their support. I am confident in the potential of Carisma’s promising technology and through the combined company, we can continue to advance our shared mission of saving and improving the lives of patients with cancer. I know the future of Carisma is bright and I am optimistic for their continued success.”
Concurrent with the closing of the merger, Carisma completed a $30 million financing from a syndicate of investors, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio. The projected cash and cash equivalents as of the close of the business combination are expected to be approximately $140 million, providing anticipated operating runway at least through the end of 2024.
In connection with the closing of the merger, a one-time special cash dividend of $75 million, or approximately $0.36 per share, will be paid no later than March 10, 2023 to Sesen Bio stockholders of record at the close of business on March 7, 2023. Under the terms of the merger, Sesen Bio stockholders also received one Contingent Value Right, which entitles the holder to receive a cash payment related to any potential proceeds from the sale of Sesen Bio’s legacy assets, including Vicineum, and the potential $30 million milestone payment under the Roche Asset Purchase Agreement.
The combined company will be headquartered in Philadelphia, Pennsylvania, and will be led by Steven Kelly, President and Chief Executive Officer of Carisma. The board of directors of the combined company will be composed of seven members, including Sanford Zweifach (Chair), Regina Hodits, Briggs Morrison, Björn Odlander, Chidozie Ugwumba, Steven Kelly (Carisma President & Chief Executive Officer) and Michael Torok.
“The successful completion of this merger marks an important milestone in Carisma’s journey and significantly strengthens its cash resources to advance the company’s differentiated pipeline and platform,” said Chairman of the Board Sanford Zweifach. “The dedication of the Carisma team, as well as the support and guidance of our advisors and stockholders, have been instrumental in bringing us to this moment. The Board and I look forward to the opportunities that lie ahead.”
SVB Securities acted as the exclusive financial advisor to Sesen Bio for the transaction, and Hogan Lovells US LLP served as Sesen Bio’s legal counsel. Evercore served as lead financial advisor to Carisma for the transaction, and BofA Securities, Inc. also served as financial advisor to Carisma for the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma. BofA Securities, Inc. and Evercore served as co-placement agents for Carisma’s concurrent financing and Shearman & Sterling LLP is serving as the placement agents’ legal counsel.
About Carisma Therapeutics
Carisma Therapeutics Inc. is a biopharmaceutical company dedicated to developing a differentiated and proprietary cell therapy platform focused on engineered macrophages, cells that play a crucial role in both the innate and adaptive immune response. The first applications of the platform, developed in collaboration with the University of Pennsylvania*, are autologous chimeric antigen receptor (CAR)-macrophages for the treatment of solid tumors. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com
*Carisma has licensed certain Penn-owned intellectual property from the University of Pennsylvania, and Penn’s Perelman School of Medicine receives sponsored research and clinical trial funding from Carisma. Penn and certain of its faculty members are current equity holders in Carisma and have received and may be entitled to receive future financial consideration from Carisma from the development and commercialization of products based on licensed Penn intellectual property.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about Carisma’s future expectations, plans and prospects, strategy or future operations, and other statements containing the words “anticipate,” “believe,” “contemplate,” “expect,” “intend,” “may,” “plan,” “predict,” “target,” “potential,” “possible,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. For example, statements concerning Carisma’s business, strategy, future operations, cash runway, the advancement of Carisma’s product candidates and product pipeline, and clinical development of Carisma’s product candidates, including expectations regarding timing of initiation and results of clinical trials are forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including without limitation: (i) risks associated with the possible failure to realize certain anticipated benefits of the merger, including with respect to future financial and operating results; (ii) the effect of the completion of the merger on Carisma’s business relationships, operating results and business generally; (iii) the outcome of any legal proceedings instituted against Sesen Bio, Carisma or any of their respective directors or officers related to the merger agreement or the transactions contemplated thereby; (iv) the ability of Carisma to protect its intellectual property rights; (v) competitive responses to the merger and changes in expected or existing competition; (vi) the success and timing of regulatory submissions and pre-clinical and clinical trials; (vii) regulatory requirements or developments; (viii) changes to clinical trial designs and regulatory pathways; (ix) changes in capital resource requirements; (x) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (xi) legislative, regulatory, political and economic developments; and (xii) other factors discussed in the Company’s reports filed with the Securities Exchange Commission. In addition, the forward-looking statements included in this press release represent Carisma’s views as of the date hereof. Carisma anticipates that subsequent events and developments will cause its views to change. However, while Carisma may elect to update these forward-looking statements at some point in the future, Carisma specifically disclaims any obligation to do so, except as required under applicable law. These forward-looking statements should not be relied upon as representing Carisma’s views as of any date subsequent to the date hereof.
Media Contact:
Julia Stern
(763) 350-5223
SOURCE Carisma Therapeutics Inc.